QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
FDA 510(k) clearance K970718 · decided 1997-05-27
Clearance details
- K-number
- K970718
- Device name
- QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
- Applicant
- R&D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-26
- Decision date
- 1997-05-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JNM
- Device class
- 2
- Regulation number
- 866.5880
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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| NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 (K992188) | Nichols Institute Diagnostics | 1999-12-06 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of sol recall (Z-2887-2016) | R & D Systems, Inc. | 2016-09-26 |